Viewpoints

BIO's president and CEO provides insight leading up to the 2011 convention.

Patent databases are often overlooked as a source of basic science, research, and development

Two films portray, in surprising detail, the hard work and determination of the biopharmaceutical industry.

Supply-chain analytics can lead to increased profitability.

US Pharmacopeia develops and improves its class approach for ensuring quality biopharmaceuticals.

Those at the top must walk the walk of uncompromising commitment to compliance

Why this workforce trend is well-suited for pharmaceutical companies.

Managing partnerships for the greater good.

The pathway for biosimilar approval in the US has been set. But are US patients too far behind Europe?

How should the industry educate the public about product quality?

In light of the new ruling, patent licensees may want to re-evaluate the strength of their licensed patents.

USP is advancing efforts to develop a guidance for evaluating bioassays.

The new US legislation will forever alter the commercial landscape for biologics.

The industry must be prepared for the impact of the sweeping changes expected from the new legislation.

This year's BIO International Convention will be occurring against a backdrop of profound change in our industry.

As a key element in the peptide production process, quality should be built into every step.

The nimbleness of biotechs makes them well suited to implementing QbD. Here's how to get started.

Drug counterfeiting has become a major problem for the FDA today; a variety of solutions is needed.

Small changes can have a big effect further downstream in your manufacturing processes.

Recent patent rulings raise significant patentability questions for DNA sequence inventions.

The Bilski and Classen decisions can render numerous in vitro diagnostic claims unpatentable.

Biopharmaceutical companies must follow an active approach to managing their supply chains.

Modern bioassays enable more accurate potency testing.

Why the industry needs to review its traditional approach to facility validation

The biopharmaceutical industry must continuously evolve to keep up with changing trends.

Single-use systems have greatly improved and simplified common manufacturing issues.

The development of a skilled labor force is essential for an expanding biopharmaceutical industry.

To achieve the right balance between disposable and reuseable options, companies must consider important technical and economic factors.